Clinical trial · Interventional
Gallium Ga 68 DOTA-NeoBOMB1 and Gallium Ga 68 PSMA-R2 PET/MRI in Diagnosing Participants With Recurrent Prostate Cancer
68Ga-NeoBOMB1 and 68Ga-PSMA R2 PET/MRI in the Evaluation of Patients With Biochemical Recurrence of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 positron emission tomography (PET)/magnetic resonance imaging (MRI) work in diagnosing participants with prostate cancer that has come back. Diagnostic procedures, such as gallium Ga 68 DOTA-NeoBOMB1 and gallium Ga 68 PSMA-R2 PET/MRI, may help find and diagnose prostate cancer and find out how far the disease has spread.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| PSA Progression | — | UNRESOLVED | — |
| Recurrent Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium Ga 68 DOTA-NeoBOMB1 | Drug | — | UNRESOLVED |
| Gallium Ga 68 PSMA-R2 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Ga68-NeoBOMB1 and Ga68 PSMA-R2
- description
- Participants receive gallium Ga 68 DOTA-NeoBOMB1 IV and 45 minutes later, undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 PSMA-R2 IV then undergo PET/MRI 45-60 minutes later.
- interventionNames
- Drug: Gallium Ga 68 DOTA-NeoBOMB1
- Device: Gallium Ga 68 PSMA-R2
- type
- EXPERIMENTAL
- label
- Arm II (Ga68 PSMA-R2 and Ga 68-NeoBOMB1)
- description
- Participants receive gallium Ga 68 PSMA-R2 IV and 45-60 minutes later undergo PET/MRI. Within 2 weeks, participants receive gallium Ga 68 DOTA-NeoBOMB1 IV then undergo PET/MRI 45 minutes later.
- interventionNames
- Drug: Gallium Ga 68 DOTA-NeoBOMB1
- Device: Gallium Ga 68 PSMA-R2
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate adenocarcinoma. * Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy). a. Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation. (i) PSA greater than 0.2 ng/mL measured after at least 6 weeks from radical prostatectomy. (ii) Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL). b. Post-radiation therapy ? American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition. (i) A rise of PSA measurement of 2 or more ng/mL over the nadir. * Able to provide written consent. * Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent). Exclusion Criteria: * Inability to lie still for the entire imaging time. * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.). * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance. * Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients. * Metallic implants (contraindicated for magnetic resonance imaging \[MRI\]).
References
Publications (1)
- DERIVEDDuan H, Song H, Davidzon GA, Moradi F, Liang T, Loening A, Vasanawala S, Iagaru A. Prospective Comparison of 68Ga-NeoB and 68Ga-PSMA-R2 PET/MRI in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2024 Jun 3;65(6):897-903. doi: 10.2967/jnumed.123.267017. PMID 38664016